BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEPACK

    MDR report key: 3832038 · Received March 7, 2014

    Report

    Report Number
    2221819-2014-00061
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 14, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENTS OF THE SYSTEM'S HARD DRIVES, MOTHER BOARD, AND COOLING FAN. SYSTEM WAS CALIBRATED AND SAFETY TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PANORAMA CENTRAL STATION, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138540 PANORAMA CENTRAL STATION WITH TELEPACK CENTRAL STATION MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1